A rapid, one step test for the qualitative detection of THC metabolites in human urine. For healthcare professionals including professionals at point of care sites. For in vitro diagnostic use only.

INTENDED USE

The THC One Step Rapid Test Strip is a rapid chromatographic immunoassay for the detection of 11-nor-Δ9 -THC-9 COOH (THC metabolite) in human urine at a cut-off concentration of 50 ng/mL. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

SUMMARY

THC (Δ9--tetrahydrocannabinol) is the primary active ingredient in cannabinoids (marijuana). When smoked or orally administered, it produces euphoric effects. Users have impaired short term memory and slowed learning. They may also experience transient episodes of confusion and anxiety. Long term relatively heavy use may be associated with behavioral disorders. The peak effect of smoking marijuana occurs in 20-30 minutes and the duration is 90-120 minutes after one cigarette. Elevated levels of urinary metabolites are found within hours of exposure and remain detectable for 3-10 days after smoking. The main metabolite excreted in the urine is 11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid (Δ9-THC-COOH).

The THC One Step Rapid Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of marijuana in urine. The THC One Step Marijuana Test Strip yields a positive result when the concentration of marijuana in urine exceeds 50 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA). 1

PRINCIPLE

The THC One Step Rapid Test Strip is a rapid chromatographic immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/mL, will not saturate the binding sites of the antibody coated particles in the test strip. The antibody coated particles will then be captured by immobilized marijuana conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above 50 ng/mL because it will saturate all the binding sites of anti-marijuana antibodies.

A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition.